PER-085-04已完成未知
A RANDOMIZED, 3-PERIOD, MULTI-DOSE, MULTICENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND CONCENTRATION PROFILE IN PLASMA OF MONTELUKAST ADMINISTERED ONCE A DAY IN ORAL GRANULES TO CHILDREN FROM 1 TO 3 MONTHS OF AGE
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2004年12月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The patient is a boy or girl> 1 month and <3 months of age at the time of administration of the drug.
- •The parent / legal guardian agrees that the patient participate in the study as indicated by the signature of the parent / legal guardian in the consent form. The patient and the parent / legal guardian are willing to comply with the procedures and are able to comply with the scheduled clinic visits.
- •It is considered that the patient has otherwise a good health according to the medical history and physical examination.
- •The patient is within 5 ° to 95 ° percentile of statue and weight for his age according to Appendix 3, but weighs at least 3.5 kg.
- •The patient has been fed powdered milk at least twice before the administration of the drug in Visit 2.
- •The patient has active bronchiolitis or a history of bronchiolitis and asthma-like symptoms.
排除标准
- •The person in charge of the care (parent / guardian) is, in the opinion of the investigator, mentally or legally incapacitated, which prevents informed consent from being obtained.
- •The patient has a history of any of the following medical conditions: Cystic fibrosis, Tuberculosis, Foreign body aspiration, Bronchopulmonary dysplasia, Tracheomalacia, Tracheoesophageal fistula, Gastroesophageal reflux, Pertussis, Congenital heart disease
- •The patient has a history of any disease that, in the opinion of the investigator, could confuse the results of the study or pose additional risks if montelukast is administered to the patient.
- •The gestational age of the patient at birth was less than 36 weeks.
- •The patient has significant or unexplained abnormalities in the pre-study physical examination and / or laboratory safety measurements
- •The patient is in a situation (for example, unreliable care of the adoptive parents, moving) or sees a condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- •The patient has a history of any clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or has a lung disease other than labronchiolitis and asthma-like symptoms.
- •The patient has a history of any clinically significant adverse event of a serious nature related to the administration of either a commercialized or investigational drug (eg, angioedema, anaphylaxis).
- •The patient has undergone surgery or participated in another clinical trial within 4 weeks prior to Visit 1.
- •The patient has taken any medication other than the permitted medications (Section I.E.2.C.) within 14 days prior to Visit 1.
- •The patient has used astemizole at any time before Visit 1.
- •The patient has used any macrolide antibiotic (except azithromycin), azole fungicides, rifampin, theophylline preparations, terfenadine and / or loratadine within 10 days prior to Visit 1.
- •The patient has used any oral p-agonist within 24 hours prior to the first dosing with montelukast at Visit 2.
- •The patient is allergic to milk powder.
- •The patient is anemic (ie, has a hemoglobin or hematocrit level below the normal range) or has an intravascular volume status that would not allow the blood sampling required for the pharmacokinetic analysis, as assessed by the investigator.
- •The patient is nursing and the mother is taking some medication that inhibits or induces the metabolism of CYP3A4.
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